Ciprofol and Remimazolam for Intraoperative Neurophysiological Monitoring During Spine Surgery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAffiliated 2 Hospital of Nantong University
About this trial
Intraoperative neurophysiological monitoring, including motor evoked potentials and somatosensory evoked potentials, is commonly used during spine surgery to help detect impending neurological injury. The quality of these signals can be affected by anesthetic agents. Ciprofol and remimazolam are newer intravenous hypnotic agents that may be suitable for total intravenous anesthesia during procedures requiring neurophysiological monitoring, but direct within-patient comparisons between the two agents are lacking. This single-center, prospective, randomized, two-sequence crossover trial will compare the effects of ciprofol and remimazolam, administered with remifentanil, on intraoperative MEP and SEP signal quality during spine surgery. Eligible participants will be randomized to receive either ciprofol followed by remimazolam or remimazolam followed by ciprofol during predefined stable intraoperative monitoring windows. The primary outcome is the within-participant difference in lower-extremity MEP peak-to-peak amplitude between the ciprofol and remimazolam periods. Secondary outcomes include SEP amplitude and latency, MEP latency, warning-threshold events, hemodynamic variables, rescue medication requirements, recovery characteristics, and postoperative neurological status.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 75 years.
Scheduled to undergo elective spine surgery.
Planned intraoperative monitoring with MEP and SEP/SSEP.
Expected surgical duration sufficient to complete two study drug periods and intraoperative monitoring windows, preferably at least 3.5 to 4 hours.
Disqualifiers
Known allergy or contraindication to ciprofol, remimazolam, benzodiazepines, propofol-related formulations, opioids, or relevant excipients.
Severe preoperative motor or sensory deficit preventing interpretable target MEP or SEP baseline recordings.
Implanted cardiac pacemaker, skull defect, or other condition considered unsuitable for transcranial electrical stimulation.
Severe neuromuscular disease, poorly controlled epilepsy, severe cognitive impairment, or inability to complete postoperative neurological assessment.
Trial design
Design model
Crossover
Treatments tested in this trial
Ciprofol
DrugCiprofol will be administered intravenously for induction and/or maintenance according to the institutional anesthesia protocol and product labeling. A suggested maintenance range is approximately 0.8 to 1.5 mg/kg/h, adjusted according to anesthetic depth, hemodynamics, surgical conditions, and patient safety.
Remimazolam
DrugRemimazolam will be administered intravenously for induction and/or maintenance according to the institutional anesthesia protocol and product labeling. A suggested maintenance range is approximately 0.5 to 2 mg/kg/h or 1 to 2 mg/kg/h, adjusted according to anesthetic depth, hemodynamics, surgical conditions, body movement, and patient safety.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Ciprofol-Remimazolam SequenceExperimental treatment 2 interventions
Group B: Remimazolam-Ciprofol SequenceExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Within-participant difference in lower-extremity MEP peak-to-peak amplitude between ciprofol and remimazolam periods
Lower-extremity target-muscle motor evoked potential peak-to-peak amplitudes will be recorded during stable intraoperative monitoring windows under ciprofol and remimazolam. The primary analysis will compare log-transformed MEP amplitude or amplitude ratio between the two drug periods within the same participant.
Time frame
During surgery, at predefined stable monitoring windows under each study drug; up to 6 hoursSecondary outcomes
1
Within-participant difference in lower-extremity SEP amplitude
Lower-extremity somatosensory evoked potential amplitudes will be compared between the ciprofol and remimazolam periods.
Time frame
During surgery, at predefined stable monitoring windows under each study drug; up to 6 hoursLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: